MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX PANCREATIC STENT KIT; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00537410
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable investigation result of advanix pancreatic stent break.Block h11: an advanix pancreatic stent was received for analysis.Visual inspection revealed that the stent loop was bent, preventing the extension of the guidewire.No other damage was noted on the device.Product analysis confirmed the reported event of the guidewire being stuck.The damage observed was most likely due to manipulation of the device during use or preparation prior to the procedure.If the anatomical structure was tortuous, the condition of the stent would not allow the guidewire to pass smoothly.Therefore, a review and analysis of all available information indicated that the most probable cause was an adverse event related to the procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was implanted in the pancreatic duct during a procedure performed on (b)(6) 2024.During the procedure, it was not possible to cross the guidewire through the stent.The guidewire got stuck in the middle of the stent loop.Another advanix pancreatic stent was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition after the procedure was reported to be stable.Note: this event has been deemed mdr reportable event based on the investigation results which revealed that the stent loop was bent.

• Brand Name: ADVANIX PANCREATIC STENT KIT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20334222
• Report Number: 3005099803-2024-04764
• Device Sequence Number: 9727957
• Product Code: FGE
• UDI-Device Identifier: 08714729856405
• UDI-Public: 08714729856405
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2024
• Device Model Number: M00537410
• Device Catalogue Number: 3741
• Device Lot Number: 0032057870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Initial Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown